BD and BioMedomics have announced the release of a new point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19 in as little as 15 minutes. A press release states that the new test, developed and manufactured by BioMedomics, will be available through BD—and distributed exclusively by Henry Schein—to healthcare providers throughout the USA.
The press release adds that the test does not require special equipment and may be used in a laboratory or at the point of care. The test detects antibodies in the blood that are produced by the body in response to coronavirus infection. These antibodies are typically present in the middle to later stages of COVID-19 infection but may remain present after exposure, which helps clinicians determine who has been exposed to the coronavirus, even if a person did not exhibit any symptoms of the COVID-19 disease. Data for past exposure is important for researchers to more accurately understand the likely true occurrence of SARS-CoV-2 infection across a population. This information will be helpful in informing future strategies for combatting COVID-19.
The test is completed in four, simple steps. First, blood is collected through normal blood collection devices such as the BD Microtainer Contact-Activated Lancet. A few drops of blood are then transferred to the test cartridge, followed by two to three drops of a buffer. The results can be read in 15 minutes, similar to how over-the-counter pregnancy tests show multiple lines for positive results and a single line for negative results.
The test analyses blood, serum or plasma samples for the presence of immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies associated with the coronavirus (SARS-CoV-2). IgM provides the first line of defence during viral infections, followed by the generation of adaptive, high-affinity IgG responses for long-term immunity and immunological memory. The detection of COVID-19 IgM antibodies tends to indicate a recent exposure to COVID-19, and detection of COVID-19 IgG antibodies indicates a later stage of infection, so this combined antibody test could also provide information on the stage of the disease in patients.
Dave Hickey, president of Integrated Diagnostic Solutions for BD, states: “Serology tests are important because they provide an additional piece of information to aid in characterising possible prior exposure to SARS-CoV-2, especially since many infections are mild or asymptomatic in severity. Initial evidence suggests that nearly all patients infected with SARS-CoV-2 will have developed a detectable antibody response within days of symptom onset, at which time a negative serologic test, along with molecular diagnostics, could be helpful in ruling out COVID-19.”
The test has not been reviewed by the FDA but is permitted for distribution and use under the public health emergency guidance issued by FDA on 16 March 2020, and BD expects to begin shipping tests in April.
BD will have capacity to supply more than one million tests over the coming months, with the ability to scale up based on market demand and is working with medical products distribution company Henry Schein to make these tests available to medical care facilities throughout the USA. Healthcare providers can order the test and all collection devices needed to perform the test by contacting their BD or Henry Schein representatives.